Qualigen announces pre-IND feedback from FDA on QN-302

Qualigen Therapeutics announces that it has received feedback from the FDA following a pre-Investigational New Drug interaction regarding the development pathway to a Phase 1 clinical trial of QN-302 for the treatment of G4-targeted advanced solid tumors. The purpose of the pre-IND interaction was to inform the proposed content of the Company’s IND application and request guidance from the Division on specific questions prior to submission of the IND application. The FDA’s response provides Qualigen with clear guidance for formally submitting an IND application for QN-302 after accounting for the agency’s comments and suggestions. "We are pleased to have received the feedback from the FDA that informs our plans for the proposed Phase 1 study intended for patients with advanced solid tumors as well as the proposed content of the initial IND application. We remain on track to submit the IND application around the first half of 2023," said Tariq Arshad, M.D., M.B.A., Qualigen’s Chief Medical Officer.